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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-004058-40
    Sponsor's Protocol Code Number:EUDARIO
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-004058-40
    A.3Full title of the trial
    A multicentre, open-label, three-arm randomised Phase II trial assessing the safety and efficacy of the HSP90 inhibitor Ganetespib in combination with Carboplatin followed by maintenance treatment with Niraparib versus Ganetespib plus Carboplatin followed by Ganetespib and Niraparib versus Carboplatin in combination with standard chemotherapy followed by Niraparib maintenance treatment in platinum-sensitive ovarian cancer patients
    Eine multizentrische, offene, dreiarmige randomisierte Phase II Prüfung zur Überprüfung der Sicherheit und Wirksamkeit des HSP90 Inibitors Ganetespib in Kombination mit Carboplatin mit nachfolgender Erhaltungstherapie mit Niraparib im Vergleich zu Ganetespib kombiniert mit Caborplatin mit nachfolgender Erhaltungstherapie Ganetespib und Niraparib im Vergleich zu Carboplatin kombiniert mit der Standard-Chemotherapie mit nachfolgender Erhaltungstherapie mit Niraparib bei Patientinnen mit einem platinsensitiven Ovarialkarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre, open-label, three-arm randomised Phase II trial assessing the safety and efficacy of the HSP90 inhibitor Ganetespib in combination with Carboplatin followed by maintenance treatment with Niraparib versus Ganetespib plus Carboplatin followed by Ganetespib and Niraparib versus Carboplatin in combination with standard chemotherapy followed by Niraparib maintenance treatment in platinum-sensitive ovarian cancer patients
    A.3.2Name or abbreviated title of the trial where available
    EUDARIO: European Trial on enhanced DNA Repair Inhibition in Ovarian Cancer
    A.4.1Sponsor's protocol code numberEUDARIO
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKatholieke Universiteit Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Union FP7 programme (grant agreement no 602602)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKatholieke Universiteit Leuven
    B.5.2Functional name of contact pointJooke de Roover
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3216347419
    B.5.5Fax number+3216347687
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGanetespib
    D.3.2Product code STA-9090
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGanetespib
    D.3.9.1CAS number 888216-25-9
    D.3.9.2Current sponsor codeGanetespib (STA-9090)
    D.3.9.3Other descriptive nameGANETESPIB
    D.3.9.4EV Substance CodeSUB88334
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNiraparib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeL-001946812-005R, L-001946812 and MK-4827
    D.3.9.3Other descriptive nameNiraparib
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Platinum-sensitive relapsed ovarian cancer
    Rezidiv eines platinsensitiven Ovarialkarzinom
    E.1.1.1Medical condition in easily understood language
    Patients with ovarian cancer
    Patientinnen mit Ovarialkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the progression-free survival (PFS) by RECIST 1.1
    E.2.2Secondary objectives of the trial
    To determine the progression-free survival (PFS)
    To determine the post-progression progression-free survival (PFS2)
    To determine the time to first subsequent therapy (TFST)
    To determine the time to second subsequent therapy (TSST)
    To determine the safety of the therapy
    To determine the objective response rate (ORR)
    To determine the patient reported outcome
    To determine the overall survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ability to understand and willingness to sign and date a written informed consent document
    • Female patients ≥ 18 year of age
    • High-grade serous, high grade endometrioid, undifferentiated epithelial ovarian, or carcinosarcoma, fallopian tube or primary peritoneal cancer
    • Platinum-sensitive relapse > 6 months after previous platinum-based treatment (calculated from the first day of the last cycle of the last platinum based chemotherapy until the date of progression confirmed according to RECIST 1.1 on imaging)
    • No limits in number of prior treatment lines
    • Measurable or evaluable disease according to RECIST 1.1
    • ECOG performance status 0-1
    • Adequate functions of the bone marrow:
    o Platelets ≥ 100 x 109/L
    o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Adequate function of the organs:
    o Creatinine < 2 mg/dl (<177 µmol/L)
    o Total bilirubin ≤ 1.5 x upper limit of normal (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
    o SGOT/SGPT (AST/ALT) ≤ 2.5 x upper limit of normal unless liver metastases are present, in which case they must be ≤ 5 x ULN
    o Urinanalysis or urine dipstick for proteinuria less than 2+. Patients with ≥ 2+ on dipstick should undergo 24-hour urine collection and must demonstrate < 1 g of protein/24 hours; except the proteinuria is clearly related to a catheter in the urinary system.
    • Adequate coagulation parameter: aPTT ≤ 1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5-2.5 x ULN), or INR ≤ 1.5. (In patients receiving anticoagulants (such as warfarin) INR must be between 2.0 and 3.0 in two consecutive measurements 1-4 days apart).
    • Participant receiving corticosteroids (dose < 10 mg/day methylprednisolone equivalent), including inhaled steroids, may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.
    • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
    • Female participant has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
    o ≥ 45 years of age and has not had menses for >1 year
    o Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating
    hormone value in the postmenopausal range upon screening evaluation
    o Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with
    medical records of the actual procedure or confirmed by imaging. Tubal ligation must be confirmed with medical records of the actual procedure,
    otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days
    after the last dose of study treatment. See below for a list of acceptable birth control methods. Information must be captured appropriately within
    the site’s source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
    o Birth Control: Participants of childbearing potential who are sexually active and their partners must agree to the use of a highly effective form of
    contraception throughout their participation beginning with time of consent, during the study treatment and for 180 days after last dose of study
    treatment(s):
     Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    • Oral route
    • Intravaginal route
    • Transdermal route
     Progestogen-only hormonal contraception associated with inhibition of ovulation
    • Oral
    • Injectable
    • Implantable
     Intrauterine device
     Intrauterine hormone-releasing system
     Bilateral tubal occlusion
     Vasectomized partner
     Sexual abstinence, if the preferred and usual lifestyle of the subject
    • Participant must agree to not breastfeed (or store breast milk for use) during the study or for 180 days afer the last dose of study treatment.
    • Haemoglobin ≥8.5 g/dl (patients may not receive a transfusion within 4 weeks prior to initiating study treatment)
    • Able to take oral medications
    • Availability of archival ovarian cancer tissue from primary diagnosis (delivery of FFPE block or slides is prerequisite for randomisation)
    E.4Principal exclusion criteria
    • Ovarian tumours with low malignant potential (i.e. borderline tumours)
    • Any prior radiotherapy to the pelvis or abdomen, or any radiotherapy encompassing > 20 % of the bone marrow within 2 weeks, or any radiotherapy within 1 week prior to Day 1 of protocol therapy.
    • Surgery (including open biopsy and traumatic injury) within 4 weeks prior to first dose of Ganetespib, or anticipation of the need for major surgery during study treatment
    • Minor surgical procedures, within 24 hours prior to the first study treatment
    • Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
    • Any serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
    • Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (> 325 mg/day).
    • Patients with a history of diagnosis, detection or treatment of any prior malignancies ≤ 2 years prior to initiating protocol therapy, except: basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated.
    • Clinically significant gastro-intestinal (GI) tract abnormalities that may increase the risk for GI bleeding and / or perforation including but not limited to: active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding; inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), history of bowel obstruction within 1 year prior to first study treatment (excluding postoperative, i.e. within 4 weeks post surgery), other GI condition with increased risk of perforation such as recurrence deeply infiltrating into the muscularis or mucosa of the rectosigmoid or the mucosa of the bladder, or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
    • Non-healing wound or non-healing bone fracture
    • Patients with symptomatic brain or leptomeningeal metastases (patients who are asyptomatic since treatment of brain or leptomeningeal metastases, eg after irradiation, are eligible)
    • Left ventricular ejection fraction (LVEF) defined by ECHO below the institutional lower limit of normal
    • Cerebrovascular accident (CVA)/ stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within ≤ 6 months prior to first study treatment.
    • Significant cardiac disease: New Yourk Heart Assiciation (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary atrial or ventricular cardiac arrhythmias
    • History of prolonged QT syndrome, or family member with prolonged QT syndrome
    • QTc interval > 470 msec when 3 consecutive ECG values are averaged
    • Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g. sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted
    • Second- or third-degree atrioventricular (AV) block, except: treated with a permanent pacemaker
    • Complete left bundle branch block (LBBB)
    • History of evidence of haemorrhagic disorders, patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorders, coagulopathy or tumour involving major vessels.
    • Participation in another clinical study with experimental therapy within 28 days before start of treatment.
    • Participant must not be simultaneously enrolled in any interventional clinical trial.
    • Women who are pregnant or are lactating
    • Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution eg. prison because of a court agreement or administrative order)
    • Subjects that are dependent on the sponsor/CRO or investigational site as well as on the investigator.
    • History of known hypersensibility against any medication used in the study
    • Intolerance / Hypersensitivity reactions to components and exipients of study drugs
    • Peripheral neuropathy of grade >2 per NCI CTCAE, version 4.03, within 4 weeks prior to randomisation
    • Any other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) by RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be done 6 months after LPI, this is expected in Q1 2020
    E.5.2Secondary end point(s)
    PFS according to pre-defined subgroups
    Post-progression PFS (PFS2)
    Time to First Subsequent Therapy (TFST)
    Time to Second Subsequent Therapy (TSST)
    Safety: Adverse events (AEs), measure according to NCI CTCAE, version 4.03
    Objective response rate (ORR)
    Patient-reported outcome (PRO)
    Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will be done 1 to 1.5 years after the evaluation of the primary end point, this is therefore expected in Q1 - Q3 2021
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis on DNA, RNA and protein level
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If participation in the trial ends due to sponsor-driven study stop, subject can continue to receive study medication if they and the investigator deem it appropriate
    If participation in the trial ends for other reasons: expected normal treatment
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation BGOG
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation AGO Austria
    G.4.3.4Network Country Austria
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation NOGGO
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation GINECO
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation MITO
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-01
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